I thought FDA did a great job yesterday during the pre-sub webinar (they mentioned that the slides and transcript would be posted next week). My comment was to the two callers who asked about submitting multiple supplements and/or submitting a pre-sub for a device that might have indications spanning two branches. There are times when we do submit multiple pre-submission supplements, namely when the lead reviewer has suggested that is an acceptable option. In those cases, for example, we might submit one pre-sub that includes the biological risk assessment and summary of biocomp testing that has been done, and one pre-sub that perhaps includes the clinical protocol. These two pre-subs will likely be triaged by the lead reviewer to the biocompatibility reviewer and medical officer on your file, respectively. Since they are going to different consults, FDA has been accepting of two pre-subs at the same time. My main suggestion is that you don't ask for two face-to-face meetings for both meetings as a telecon or written feedback alone should be sufficient.
I've been part of a few meetings where FDA has brought in representatives from multiple branches to address the multiple potential indications of a device. This can be very valuable as different branches might have insight into what pathway might be more direct for a company. Additionally, they might reduce burden by suggesting testing that could span the indications and save a company some time and money.
I would discourage sending in multiple pre-subs when you've simply forgotten to ask something in your previous pre-sub and want to try to tack on more questions or data. While FDA allows multiple pre-submissions for a device, you can wear our your welcome if not careful!
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Allison Komiyama
AcKnowledge RS
San Diego CA United States
www.acknowledge-rs.com/regulatoryaf------------------------------
Original Message:
Sent: 12-Jun-2019 14:07
From: Anonymous Member
Subject: Global Regulatory Strategies and Best Practices Ask Me Anything Session
This message was posted by a user wishing to remain anonymous
@Allison Komiyama, I heard you in the pre-submission webinar hosted by FDA yesterday. During the Q&A session, you mentioned that in a few cases FDA was open to companies sending in multiple pre-submissions concurrently. Can you explain when that has been useful to get FDA feedback and when it is discouraged?
Original Message:
Sent: 12-Jun-2019 13:29
From: Emily Stamm
Subject: Global Regulatory Strategies and Best Practices Ask Me Anything Session
Hi Members,
Recently, RAPS released it's quarterly article series focusing on global regulatory strategies and best practices. Today, we are joined by four experts, @Allison Komiyama, @Emily Huddle, Kirsten Messmer, and @Melissa Walker ,who will be discussing the articles in real-time and available to answer your questions.
Please use this thread to ask the experts your questions.
Can't wait to read the discussions!
Best,
Emily
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Emily Stamm
Community Manager
Regulatory Affairs Professionals Society®
regex@raps.org
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